Regulation 178 New paragraphs 30A and 30B

After paragraph 30 insert—

“Autogenous vaccines

30A.

(1)

The fee for the scientific assessment of an authorisation (or an application for authorisation) to manufacture an autogenous vaccine is £6,962.

(2)

The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) to manufacture autogenous vaccines are set out in the following table—

Inspection fees

Type of site	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	21,416	22,710
Major site	12,850	14,144
Standard site	6,425	7,719
Minor site	4,283	5,577

Assessment of a variation of an authorisation to manufacture an autogenous vaccine

30B.

The fee for the scientific assessment of an application for the variation of an authorisation to manufacture an autogenous vaccine is—

(a)

£2,895 if the variation requires complex scientific or pharmaceutical assessment;

(b)

£885 if the variation requires simple scientific or pharmaceutical assessment;

(c)

£455 in relation to an administrative variation.”.